R&D Quality Engineer
Madison, WI 
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Posted 20 days ago
Job Description

Give hope. Give health. Make your mark in the fight against cancer.

At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer - helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.

Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makestreatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.

Job Description

Summary:

The Senior Product Development Quality Engineer works with the cross-functional R&D teams to develop and maintain high quality development practices to ensure products are developed with high quality considerations throughout the product development process.

The Senior Product Development Quality Engineer is a change agent responsible for promoting a culture of quality and leading the development and deployment of engineering improvement initiatives to provide improved designs and better predictability for Product Development schedules.

Essential Duties and Responsibilities:

  • Identify and drive continuous improvement opportunities and develop key metrics to ensure achievement of expected outcomes.

  • Create quality metrics and employ qualitative analysis to measure the quality of Product Development activities.

  • Oversee gap assessments on Product Development processes and work with functional areas to improve processes.

  • Effectively utilize problem-solving tools/methodology.

  • Advise and participate in root-cause analysis.

  • Provide CAPA guidance and assistance.

  • Provide assistance with audit support activities.

Qualifications:

a. Required

  • A Bachelor's degree in related engineering or technical field.

  • Minimum of 7 years of experience in quality engineering or related field for medical device development.

  • Excellent negotiation, organizational, leadership and interpersonal skills.

  • Ability to lead and motivate change management, and influence without authority.

  • A working understanding of regulations and standards relevant to medical devices.

  • Ability to employ and provide guidance with problem-solving tools and methodologies.

  • Strong verbal and written communications skills, and ability to function with minimal supervision.

b. Preferred or Desired

  • Experience working through all aspects of device design and development including:

    • Hardware & Software development

    • Design verification & validation

    • Process validation

    • Design Transfer

  • Experience performing root cause analysis and CAPA

  • The ability to perform statistical analysis

  • Six Sigma certification preferred

#LI-ML1

To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top - and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin - including individuals with disabilities and veterans.


We are an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
7+ years
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